Viewing Study NCT03483740



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Last Modification Date: 2024-10-26 @ 12:43 PM
Study NCT ID: NCT03483740
Status: COMPLETED
Last Update Posted: 2024-03-29
First Post: 2018-01-09

Brief Title: Psychosocial Intervention for Older HIV Adults With HAND
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: Cognitive Remediation Group Therapy to Improve Older Adults Ability to Cope With HIV-Associated Neurocognitive Disorder HAND
Status: COMPLETED
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IN-HAND
Brief Summary: CTNPT 029 will test the feasibility and acceptability of cognitive remediation group therapy in older adults living with HIV who have been diagnosed with HIV-associated neurocognitive disorder HAND The cognitive remediation therapy will include tablet-based cognitive training and mindfulness-based stress reduction sessions
Detailed Description: Approximately half of the aging HIV-positive population will be affected by HAND making cognitive impairment related to HIV a significant comorbidity in this population With the development access to and early initiation of modern antiretroviral therapy ART HAND is less severe and less common than it once was However people who were treated with old therapies ones that were less effective and with higher rates of toxicity compared to current regimens or who experienced AIDS defining illnesses may be affected by HAND more frequently and more severely Issues with cognition memory processing new information problem solving and decision making are all potential symptoms

Psychosocial interventions have been used to decrease stress and depression and improve coping and quality of life in the general aging population experiencing cognitive impairment and depression These techniques which can vary widely have not been fully tested in people aging with HAND

CTNPT 029 a pilot trial funded by the CTN seeks to enroll 16 people at St Michaels Hospital in Toronto Study participants will be randomized to either receive cognitive remediation group therapy CRGT or standard HIV group therapy control group Both group therapies consist of a series of weekly 3-hour sessions led by a certified social worker and a peer The CRGT group will spend one hour per session on brain training exercises PositScience Software and the remaining two hours on mindfulness-based stress reduction meditation breathing exercises etc The control group will focus on general health and wellbeing for people aging with HIV Study investigators will determine the usefulness of the structure of the sessions and the feasibility and acceptability of performing a study of this kind

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None